Foralumab nasal spray continues to show long-term safety in SPMS: Data
Patients remained stable or improved within six months of starting treatment
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- Foralumab nasal spray for SPMS shows long-term safety.
- No drug-related serious side effects reported in patients using foralumab for up to 3.5 years.
- Treatment aims to calm immune responses and reduce microglia activity in the brain.
Tiziana Life Sciences‘ intranasal spray foralumab continues to be safe and well-tolerated, with no drug-related serious side effects reported after long-term use, according to an annual report filed with the U.S. Food and Drug Administration (FDA).
The company is developing foralumab for neuroinflammatory diseases such as multiple sclerosis (MS), Alzheimer’s disease, and multiple system atrophy.
Most of the data came from 14 patients with nonactive secondary progressive multiple sclerosis (SPMS) who received foralumab nasal spray for periods ranging from about six months to 3.5 years in an open-label expanded access program (NCT06802328). This program provided access to foralumab nasal spray outside clinical trials, and participants remained stable or improved within six months of starting treatment.
“We have seen 37.4 patient-years of cumulative foralumab exposure with no study drug-related serious adverse events, a milestone that reinforces the safety of our intranasal approach,” Ivor Elrifi, PhD, CEO of Tiziana, said in a company press release. Patient-years are a measure of exposure that combines the number of patients treated and the duration of their treatment.
Foralumab targets key protein on immune T-cells
In all types of MS, the immune system mistakenly attacks myelin, the protective coating surrounding nerve cells, causing inflammation and damage in the brain and spinal cord.
While most people with MS start by experiencing relapses, which are periods when symptoms suddenly worsen, some patients eventually transition to a secondary disease state called SPMS in which symptoms steadily worsen, even in the absence of relapses.
Nonactive SPMS is a form of MS in which patients have no evidence of relapses or new inflammatory lesions on MRI scans, though the disease will continue to progress via different mechanisms.
Foralumab is an antibody therapy designed to target the CD3 protein on immune T-cells. This is expected to activate regulatory T-cells, which help calm mistaken immune responses, while suppressing the pro-inflammatory T-cells that cause damage in MS.
The therapy has also been shown to reduce the activity of microglia, the brain’s resident immune cells that contribute to MS progression in nonactive SPMS and other progressive forms of MS.
Developer currently conducting larger study of therapy
In addition to the expanded access program, Tiziana is running a larger Phase 2a clinical study (NCT06292923) that is testing foralumab in up to 54 adults with nonactive SPMS. The study, which “will read out in 2026,” according to Elrifi, may still be recruiting at sites in the U.S.
Participants in the trial are being randomly assigned to receive intranasal foralumab at either of two dose levels or a placebo for about three months. The main goal is to see if foralumab is safe and confirm that it can reduce the activity of microglia. After the placebo-controlled phase, all patients may receive foralumab for an additional six months to study its longer-term effects.
The seventh annual Development Safety Update Report submitted to the FDA covers the period from Sept. 21, 2024, to Sept. 2, 2025, and a total of 37.4 patient-years of exposure. Patients in the expanded access program contributed 30.7 patient-years to the total, and the Phase 2 trial and its open-label extension added about 5.2 patient-years of exposure.
One patient with moderate Alzheimer’s also received foralumab for 28 weeks as part of an expanded access program, contributing another 0.5 patient-years
Across all studies, no serious side effects were linked to intranasal foralumab, and the side effects reported during this period did not reveal new safety concerns. Based on this safety update, no changes to study plans are needed to address foralumab safety.
